510(k) K243849 ยท MUE Full Field Digital, System, X-Ray, Mammographic
2430TCA with Xmaru W
| Applicant | Rayence Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Mar 12, 2025 |
| Received | Dec 16, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243849
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.